India, Dec. 15 -- Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences (Zydus Group), today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for copper histidinate (CUTX-101), intended to treat Menkes disease in pediatric patients. The resubmission has been accepted as a Class I response and as a result, the Company has received January 14, 2026 as the new PDUFA date. Sentynl resubmitted its revised NDA on 14 November 2025 after receiving a complete response letter (CRL) from the FDA on 30 September 2025, which cited observations regarding the manufacturing site's cGMP compliance. The CRL did not cite any othe...